{"recall":{"id":"fda-device-99228","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medtronic MiniMed, Inc. recalls MiniMed Go App","firm":"Medtronic MiniMed, Inc.","date":"2026-06-16","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)","code":"Model/UDI-DI: MMT-8600/00199150038978(10)1.1.0, MMT-8601/00199150038985(10)1.1.0 Software Versions: 1.0.0, 1.1.0","quantity":"3,465","number":"Z-2778-2026","classification":"Class II"}],"reason":"For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the states and territories of PR, OH, WA, IL, NC, PA, VA, MN, ID, CA, UT, MI, NJ, MS, SC, CO, AZ, OR, AR, MO, TX, AL, FL, NY, IN, TN, IA, WI, MA, LA, OK, GA, KS, NM, CT, KY, NH, NV, MD and the countries of Australia, Switzerland, Germany, Denmark, Spain, Finland, Iceland, Norway, Sweden.","nationwide":true,"states":[],"units":"3,465","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99228","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"0b00c15f8d23159e","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99228","record":[{"status":"Ongoing","city":"Northridge","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99228","recalling_firm":"Medtronic MiniMed, Inc.","address_1":"18000 Devonshire St","address_2":"N/A","postal_code":"91325-1219","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states and territories of PR, OH, WA, IL, NC, PA, VA, MN, ID, CA, UT, MI, NJ, MS, SC, CO, AZ, OR, AR, MO, TX, AL, FL, NY, IN, TN, IA, WI, MA, LA, OK, GA, KS, NM, CT, KY, NH, NV, MD and the countries of Australia, Switzerland, Germany, Denmark, Spain, Finland, Iceland, Norway, Sweden.","recall_number":"Z-2778-2026","product_description":"MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)","product_quantity":"3,465","reason_for_recall":"For MiniMed Go app version 1.0.0 and 1.1.0, when the  Set day and night  is turned OFF and  missed dose  or  Correct high glucose  alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.","recall_initiation_date":"20260616","center_classification_date":"20260723","report_date":"20260729","code_info":"Model/UDI-DI: MMT-8600/00199150038978(10)1.1.0, MMT-8601/00199150038985(10)1.1.0  Software Versions: 1.0.0, 1.1.0"}]}}